Study of Oral Anthocyanins on Insulin Resistance

Dietary strategies for alleviating the metabolic complications such as diabetes associated with obesity are actively being pursued as alternatives to pharmaceutical interventions The genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a source of folk remedies for established diabetic symptoms, primarily as leaf or stem infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB) are enriched in anthocyanins, polyphenolics recognized for their ability to provide and activate cellular antioxidant protection, inhibit inflammatory gene expression, and consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity. The association of obesity with adipose tissue stress, macrophage recruitment, and inflammatory gene expression suggests that eating edible berries from this genus might provide an effective alternative or supplementary intervention to attenuate obesity- associated inflammation and the associated insulin resistance.

The aim of this study is to determine the effects of anthocyanin supplementation in the form of a concentrated blaeberry extract on insulin resistance and inflammation particularly in the adipose tissue following a three week supplementation period.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, AB21 9SB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Obese male subjects (BMI > 30)
Aged > 40 and < 70 years of age
Type 2 diabetes; subjects controlling their diabetes by diet alone or with impaired glucose tolerance
All the obese subjects will have a waist circumference over 40 inches
All subjects must live the Aberdeenshire area of Scotland

Exclusion criteria

Medical exclusion criteria:

Chronic illness, including:

thromboembolic or coagulation disease,
unregulated thyroid disease,
kidney disease,
hepatic disease,
severe gastrointestinal disorders,
pulmonary disease (e.g. chronic bronchitis, COPD),
Alcohol or any other substance abuse,
Eating disorders,
Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders),
Skin conditions on the abdomen,
Allergy to skin dressings,

Medication exclusion criteria:

Oral steroids,
Tricyclic antidepressants, neuroleptics,
Anticoagulants,
Digoxin and antiarrhythmics,
Chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen),
Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin

Treatment and study plan

Mirtoselect

Dietary Supplement

Male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.

Volunteers will be given either a total daily dose of 1.4 grams of concentrated blaeberry extract (mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/) in a hard gelatin capsules or control capsules containing lactose administered thrice a day for 21 days.

Primary outcomes

Oral Glucose Tolerance Test

Time frame: Day 0 and 21 days post intervention

Change in Oral Glucose Tolerance following intervention

Secondary outcomes

Fasting blood glucose/insulin

Time frame: Day 0, 7, 14, and 21 days post intervention

Change in fasting blood glucose/insulin in response to intervention

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2019
Study completion: 2019
First posted: Aug 12, 2010
Registry last updated: Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed